亮菌甲素注射液应急检验排查实践研究(三)  

Practice Research on Emergency Testing Investigation of the Armillarisin A Injection(Ⅲ)

作　　者：谢志洁[1] 杨德忠[1] 陈勇[1] 肖树雄[1] 雷毅[1] 

机构地区：[1]广东省药品检验所,广州510180

出　　处：《中国药事》2009年第5期430-435,共6页Chinese Pharmaceutical Affairs

基　　金：国家食品药品监督管理局2007年实践科学监管理念课题成果一等奖

摘　　要：目的提出了药品质量应急检验排查应当遵循的职责导向思维、循症溯源思维、循证系统思维。方法应用信息资料排查法、标准检验排查法、实验设计排查法。结果构建了由应急分类、误区禁忌、准备预案、组织职责、响应动员、程序步骤、报告沟通、总结评估等内容组成的药品质量应急检验排查的基本模式。结论界定了药品质量应急检验排查的概念、对象、特点、原则。Objective Raised that the emergency testing investigation of drug quality should be guided by the oriented functions of thinking, thinking back through the disease, evidence-based systematic thinking. Methods The information data investigation method, the standard test investigation method and experimental design investigation method were used. Results Constructed the basic mode for the emergency testing investigation of drug quality, the composition is emergency classification, errors taboo, prepare plans, organizational duties, response mobilization, process steps, report communication and summary assessment. Conclusions To define the quality of the conclusions of emergency drugs test the concept, the targets, the characteristics and the principle of the emergency testing investigation of drug quality.

关 键 词：药品质量 应急检验 排查 模式 

分 类 号：R95[医药卫生—药学] R927.11